Moderna hasn’t breached its vaccine contract despite repeated delivery concerns: Anand

Moderna has not violated its contractual obligations with Canada, Procurement Minister Anita Anand says, despite continued setbacks over promised COVID-19 vaccine deliveries to this country.

“There has not been a breach of contract at this stage, and indeed, strong relationships with our suppliers [have] been fundamental to ensuring that we’ve accelerated 22 million doses already from one quarter to the next,” Anand said in an interview on Rosemary Barton Live.

The minister’s comments come as a shipment of 1.2 million Moderna doses bound for Canada this month has been scaled back and delayed.

The shots, which were set to arrive this week, have been slashed to 650,000 doses and will now arrive later in April or by early May. A further 12.3 million doses expected to arrive by the end of June will also shrink by one to two million shots and are now scheduled to show up between July and September.

The Massachusetts-based company is struggling to meet ramped-up global demand at its European facilities, partly due to labour shortages.

“Moderna continues to make substantial capital investments to support production increases … and explore other potential collaboration opportunities,” the company said in a statement on Friday.

Public Services and Procurement Minister Anita Anand says Moderna hasn’t contravened its COVID-19 vaccine contract with Canada, even though deliveries of the company’s mRNA vaccine continue to experience delays. (Adrian Wyld/The Canadian Press)

Flexible contracts allow for accelerated deliveries

Both Moderna and Pfizer wrestled with production holdups earlier this year as the companies scaled up their capacity to handle increased demand — but Pfizer has maintained a consistent delivery schedule since then.

“Pfizer has been an incredibly stable partner in the bringing in of vaccines to this country,” Anand told CBC chief political correspondent Rosemary Barton.

“We continue to ask them for earlier and earlier doses, and they continue to ensure that we are able to do that.”

On Friday, Prime Minister Justin Trudeau said Canada signed an agreement with the pharmaceutical giant for eight million more doses of its mRNA vaccine.

FedEx workers in Toronto offload a plane carrying Moderna vaccine doses originating from Europe in March 2021. (Nathan Denette/The Canadian Press)

The country is not paying a premium for the accelerated deliveries, Anand said.

“We are paying fair market value for these doses, and they are obliging our requests. We exercised options for those eight million doses, and we had built that flexibility into our contracts.”

The minister said the nature of Canada’s agreements with its suppliers means delivery schedules are not necessarily set in stone.

“The ability for Canada to bring in increasing numbers of doses goes back to the diversified portfolio of vaccines that we put in place back last August, and [we] made sure that we have flexibility here so that we can draw down on our contractual arrangements.”

Accessing U.S. supply

When asked at what point the United States might be able to open up access to its vaccine stocks, Anand said she’s not focused on that country’s supply chain.

“I’m not focused on the U.S. timeline as much as I am on ensuring we’re having those discussions right now, and that’s why we have been engaged with the U.S. administration since January,” she said.

So far, Canada has received 1.5 million AstraZeneca-Oxford doses on loan from its southern neighbour that will be returned later this year.

“We are in constant discussion with the United States and will continue to do that through our ambassador, Kirsten Hillman, and with her excellent help in order to have Canada as being well placed to continue to draw doses from multiple countries, not just the U.S.,” Anand said.

You can watch full episodes of Rosemary Barton Live on CBC Gem, the CBC’s streaming service.

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Experts probe possible link between vaccine and woman's death; Federal Court rules Google misled customers on location data; PM flags future of international travel; Royals prepare for Prince Philip's funeral

By Tom Livingstone16 Apr 2021 07:02Scott Morrison thanked the Australian Defence Force personnel who are in Kalbarri and surrounding areas, helping with the recovery effort after Cyclone Seroja swept through on the weekend.He also commended the local SES who helped ensure some 7000 locals were safely evacuated prior to the storm hitting.”Some 7000 or so weren’t there. People who were in this town before that cyclone hit and the commander of the local SES made sure that people got out. That clearly saved lives,” Mr Morrison said.”That quick thinking, that experience that was needed in that moment, the work that was done as a community to get people to safety was extraordinaryand we are now in the position where the injuries here are minor, substantially, and there has certainly been no loss of life and that is, indeed, a miracle, given what we’ve seen happen as a result of this terrible cyclone.”

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Scientists exploring possible link between Johnson & Johnson, AstraZeneca vaccine blood clot issues

Doctors, scientists and public health experts are turning to Europe for clues, where a similar vaccine made by AstraZeneca — not yet authorized in the U.S. — also has been linked to a number of rare blood clots.

“It’s hard to say if it’s the same problem,” said Dr. Richard Kuhn, Ph.D., a virology expert at Purdue University, “but it does seem the vaccine triggers an antibody response that activates platelets, leading to clots.”

While many experts have hesitated to say for sure if there is a link, Schaffner said there’s a growing consensus in the scientific community after none of these rare clots have been linked to the Pfizer or Moderna vaccines, which use mRNA, a different technology.

“I think we shouldn’t be coy about that any longer,” Schaffner said, adding that it may be time to “accept the fact that these are vaccine-induced but very rare events.”

But experts cautioned that even if there is a link, current evidence suggests the risk of developing a blood clot after getting the Johnson & Johnson vaccine is exceedingly low — lower, in fact, than being struck by lightning.

Responding to a report on one of the six clot cases published in the New England Journal of Medicine, Johnson & Johnson penned a response Friday, insisting a clear link has not yet been established.

“At this time, evidence is insufficient to establish a causal relationship between these events and the [Johnson & Johnson] vaccine,” Janssen scientists said, adding that the vectors used in their vaccine and AstraZeneca’s are “substantially different” and that those differences could lead to “quite different biological effects.” The researchers added that “more evidence is needed” to further clarify the cause of this clotting, combined with low platelet count in those receiving the COVID-19 vaccine.

Next week, the Centers for Disease Control and Prevention’s independent advisory committee will review all evidence and make a recommendation about whether to resume using J&J vaccines.

Different theories

Still with more questions than answers, scientists are exploring different theories about why this type of shot — called a viral vector vaccine — might cause rare clotting problems.

Vaccines work by prompting our immune systems to develop antibodies against a virus, and a prevailing theory is that viral vector vaccines somehow trigger an abnormal immune response, leading to the blood clots.

Scientists in Germany identified a specific antibody in many people who developed clots after receiving the AstraZeneca vaccine — and U.S. researchers subsequently identified the same antibody in individuals who developed similar clots after getting a J&J vaccine. In these subjects, the body’s immune system has formed antibodies that attach to platelets, the specialized blood cells that join together to form clots.

“It’s not the vaccine that’s causing it — it’s the body’s immune response to the vaccine,” said Dr. Alex Spyropoulos, a blood clot specialist and professor at the Feinstein Institutes for Medical Research.

Experts say the condition, cerebral venous sinus thrombosis, or CVST, is exceedingly rare.

The Food and Drug Administration and CDC said that in the six women who experienced a clot, the problem manifested six to 13 days after receiving the shot, a time frame that tracks with an immune response, Spyropoulos said.

It’s still not clear why a vaccine would trigger this cascade of events, but researchers said it mimics another well-documented reaction to heparin, a common blood thinner. For this reason, the CDC and FDA have warned against using heparin to treat anyone recently vaccinated with the Johnson & Johnson vaccine.

Existing evidence from the United States and Europe hints that women may be at greater risk – perhaps in part because women are already more likely than men to develop CVST, based on previous data.

“We have to be careful about the assumptions we make,” Spryopoulos cautioned, “especially given how infrequent these events have been.”

It’s possible similar cases will develop in men, but if the CDC advisory panel concludes that the risk is higher in women, the FDA could move toward a black box warning — a label for drugs and medical devices with potentially serious side effects – on the Johnson & Johnson vaccine for certain women.

Though the abrupt halt to an already authorized vaccine may instill concerns and foment hesitancy around the vaccine, experts said it’s a good sign drugs are being properly vetted for safety.

“I really want to stress to the public that they need to remain confident in our concepts and the times regarding vaccines in general,” said Dr. Jason Goldman, an internal medicine doctor representing the American College of Physicians on the expert panel said, adding that members of the general public should “not to let this sour your decision on getting vaccinated in general.”

“We do have confidence in the process,” Goldman added. “And we will make the right decision regarding public safety.”

Amanda Benarroch, M.D., a psychiatry resident at Mayo Clinic in Rochester, Minnesota, is a contributor to the ABC News Medical Unit. ABC News’ Sasha Pezenik and Sony Salzman contributed to this report.

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Disability advocates urge Morrison government to fix vaccine rollout

Residents and carers in Australia’s disability support homes are still waiting for their first dose of the virus vaccine despite being a priority group.

Disability advocates are urging the government to fix Australia’s vaccination rollout, with the majority of the sector still waiting for their first coronavirus jab.

Disability accommodation providers and residents were supposed to be included in the first phase of the national rollout, which targets the country’s most vulnerable residents.

National Disability Services chief David Moody says the sector is keenly awaiting the result of Monday’s national cabinet meeting in the hopes a tangible plan is developed to get the rollout back on track.

He understands that it is a huge logistical exercise.

“That said, we are frustrated, very frustrated, and concerned about the lack of vaccine going into people’s arms which should have been under phase 1a,” Mr Moody told AAP.

“The reason why the disability sector was identified for priority access for the vaccine is because we know, based upon research, that people with disability often suffer much harsher impacts as a result of getting COVID-19.”

Mr Moody wants to know how and when people in disability accommodation will receive vaccinations.

Prime Minister Scott Morrison will meet his state and territory counterparts on Monday as they grapple with updated health advice that has put them back to the drawing board for the vaccine rollout.

The leaders will meet twice weekly until it is on track.

Most Australians were supposed to receive the AstraZeneca vaccine but that has been linked to rare blood clots so people under the age of 50 have been told to get the Pfizer option instead.

The Commonwealth has primary responsibility for vaccinating disability care residents and has contracted private companies to deliver the jabs.

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Covid-19: Vaccine passports ‘unethical’, church ministers warn

More than 1,200 church ministers in the UK have urged PM Boris Johnson not to introduce coronavirus vaccine certificates, saying they are an “unethical form of coercion”.

In an open letter, Anglican and Catholic ministers warned passports could create a “surveillance state”.

A government review is looking into whether people should have to prove they have been vaccinated.

The UK equality watchdog said passports could create a “two-tier society”.

Government ministers have said that certificates would allow people to show if they have been vaccinated, had a negative test or had natural immunity from a confirmed infection in the previous six months.

As restrictions ease, certificates could play a role in reopening theatres, nightclubs and mass events like festivals, plus allow social distancing to be relaxed in hospitality venues, the government has said.

But in the letter to the prime minister, church ministers warned that introducing the passports would create a “medical apartheid”.

“This scheme has the potential to bring about the end of liberal democracy as we know it and to create a surveillance state in which the government uses technology to control certain aspects of citizens’ lives,” the letter states.

“As such, this constitutes one of the most dangerous policy proposals ever to be made in the history of British politics.”

The ministers said that, regardless of the government’s final decision, they would not refuse entry to their churches to anybody without a vaccine passport – or any other certificate which they have labelled “proof of health”.

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Death of NSW woman who suffered blood clotting ‘likely’ linked to AstraZeneca coronavirus vaccine

The TGA says the death of the 48-year-old who developed blood clots after receiving the AstraZeneca shot “is likely to be linked to vaccination”.

The fatal blood clotting suffered by a woman in NSW is “likely” linked to the AstraZeneca COVID-19 vaccine she received, Australia’s medical regulator has announced. 

The revelation came in a statement late on Friday night from the Therapeutic Goods Administration (TGA).

The TGA’s Vaccine Safety Investigation Group (VSIG) met on Friday and concluded the blood clotting in the 48-year-old woman’s arteries and veins, as well as her low platelet count, was “likely to be linked to vaccination”.

She was vaccinated with the AstraZeneca shot on 8 April and admitted to hospital four days later, where she died.

The review of the woman’s death was complicated by her underlying medical conditions, including diabetes, and “some atypical features”, the TGA’s statement said.

It said “anti-PFA antibodies” – which activate platelets, and have been found in almost all other internationally reported blood clot cases – were also absent. 

“Despite the atypical clinical features and the negative antibody test, in the absence of an alternative cause for the clinical syndrome, [VSIG] believed that a causative link to vaccination should be assumed at this time,” the statement said. 

This is the third report of a case of the rare blood clotting disorder linked to the AstraZeneca vaccine in Australia and the first death. The other two cases are being treated in hospital and have been recovering well.

Last Thursday, adults in Australians under the age of 50 were warned off receiving the AstraZeneca shot, with Pfizer becoming the preferred vaccine for that demographic. 

The TGA said the woman who died was vaccinated before authorities made the decision later that day, it said in its Friday statement.

Laboratory tests from the woman are still pending and an autopsy will be conducted next week. 

“Given this is an atypical presentation, should the test results and autopsy provide an alternative causation, VSIG would review their decision,” the TGA said.

TGA chief John Skerritt said this week that blood clotting associated with the AstraZeneca vaccine was so rare that “your chances of winning the lotto are much higher”, with the regulator’s Friday statement saying the three cases in Australia so far equated to a frequency of one in 295,000.

Earlier on Friday, Chief Medical Officer Paul Kelly urged people to continue to get vaccinated, saying the benefits far outweighed any harm.

He said he had read one unpublished overseas study that suggested COVID-19 brought a risk of blood clotting itself.

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13 Americans Share the Personal Reasons Why They Got COVID-19 Vaccine – E! Online

Hope is here!

With the COVID-19 vaccine becoming more readily available throughout the United States, health experts are encouraging the public to make an appointment, roll up their sleeves and get vaccinated.

For some, getting the shot means family reunions, weddings, graduations, quinceañeras and vacations can begin again. But for others like Dr. Cedric “Jamie” Rutland, vaccinations mean less severely sick people and hospitalizations.

“Americans should get vaccinated to prevent severe COVID-19 and death from coronavirus,” the pulmonary/critical care doctor and National Spokesperson for American Lung Association in Orange County, Calif shared with E! News. “The vaccine acts as a ‘scout’ preparing the immune system for the actual virus exposure. This allows the white blood cells to act efficiently, effectively and organized to prevent a severe inflammatory response, which is what kills people with severe COVID-19.”

In simple terms, scientists and health care workers fighting COVID-19 on the front lines believe this vaccine will save lives.

If you still need persuading, familiar faces like former First Lady Michelle Obama, Dr. Anthony Fauci, Lin-Manuel Miranda and Matthew McConaughey will appear on NBC’s Roll Up Your Sleeves vaccination special airing Sunday, April 18 at 7 p.m. The hour-long special aims to raise awareness and encourage Americans to help put an end to the pandemic by getting vaccinated.

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Australia’s slow vaccine rollout in aged care prompted one provider to go it alone

Australia’s progress in vaccinating some of its highest-priority citizens has been slower than anyone wanted, but one Melbourne aged care provider is streets ahead of the rest.

In the next few weeks, private provider TLC Aged Care is likely to become the first residential aged care company to have all residents and staff fully vaccinated against COVID-19.

They’ve got there by taking matters into their own hands.

“We really didn’t want our residents, staff or contractors to endure another winter with the nervousness and trepidation that they have endured over the last 16 months,” CEO Lou Pascuzzi said.

“We’ve got immunisation capabilities and primary care capabilities.

“We decided to approach the government …  and ask for permission to administer phase 1a ourselves.”

The federal government agreed to send Pfizer doses, and TLC Aged Care started immunising in the second week of March.

“We’re now three weeks away from completing double doses for all of our 1,500 residents and 2,000 staff and contractors,” Mr Pascuzzi said.

The company is also claiming a high uptake rate for the vaccine, with 91.25 per cent of staff and residents taking up the opportunity to get a shot.

But the TLC model is not one that can be rolled out widely in aged care, as most residential homes don’t have the medical facilities or expertise to deliver immunisations.

Nationally, around 153,000 doses have been administered in the Commonwealth aged care rollout as of yesterday.

That represents around a quarter of the vaccination program for just residents of aged care homes.

Vaccinations have taken place in at least 1,121 sites, representing around 40 per cent of all residential aged care homes.

Many homes still don’t know when they’ll get a visit from Commonwealth vaccination teams, including Alwyndor aged care in Adelaide’s south.

“The rollout has been slower than we’d anticipated — a number of care homes in the surrounding areas have had theirs,” said general manager Beth Davidson-Park said.

The vast majority of the doses in the sector have so far gone to residents, with workers in the sector waiting on the sidelines.

They may be waiting some time.

The changed advice for the administration of the Oxford-AstraZeneca vaccine to those under 50 means those workers no longer have a timeline on which they’ll be inoculated.

“Our advice to staff has been to contact their GP and get their vaccination independently of work,” Ms Davidson-Park said.

The Prime Minister said his priority is still to vaccinate those most vulnerable in our community in phases 1a and 1b, “particularly those Australians aged over 70”.

“Right now, our focus is on vaccinating people for whom the AstraZeneca vaccine does not present a challenge,” Scott Morrison said yesterday.

“Those supplies are continuing to roll out.”

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AstraZeneca’s Oxford vaccine trial to resume

The university, which is developing the vaccine with AstraZeneca, did not say when the trial would resume. AstraZeneca said the trial will only resume in the United Kingdom, adding that it’s working with health authorities across the world to determine when other trials can resume.

Before the pause, the company was testing its vaccine, dubbed the Oxford vaccine, in the United States as well as in the United Kingdom, Latin America, Asia, Europe and Africa.

The university said in a statement that some 18,000 individuals around the world have received study vaccines as part of the trial. “In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” the statement added.

US National Institutes of Health Director Dr. Francis Collins told a Senate hearing Wednesday that pausing a trial was a standard precaution that is meant to ensure experimental vaccines don’t cause serious reactions among participants.

“To have a clinical hold, as has been placed on AstraZeneca, as of yesterday, because of a single serious adverse event, is not at all unprecedented,” Collins said at a hearing of the Senate Heath, Education, Labor and Pensions committee.

On Tuesday, AstraZeneca joined eight other companies in signing a pledge promising they would not seek premature government approval for any coronavirus vaccine. The companies promised to wait until they had adequate data showing any potential vaccine worked safely.

AstraZeneca did not provide any details on the issue that caused the trial to stop. While AstraZeneca didn’t specify what the issue was, at the hearing on Wednesday Collins said the AstraZeneca hold was due to a “spinal cord problem.”

On Wednesday, AstraZeneca issued a statement denying news reports that suggested the trial was stopped because of a case of transverse myelitis — a rare inflammatory condition of the spinal cord. On the same day, AstraZeneca said it had paused its coronavirus vaccine trial not once but twice because of adverse events.

“We can also confirm that there was a brief trial pause in July while a safety review took place after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis, which the independent panel concluded was unrelated to the vaccine,” a company spokesperson said.

The AstraZeneca vaccine is one of three coronavirus vaccines in late-stage, Phase 3 trials in the US. It has the backing of the US federal government. Moderna and Pfizer/BioNTec are the other two groups with Phase 3 trials under way, also with federal government funding.

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Logistical concerns over rollout of Pfizer COVID-19 vaccine to remote Queensland communities

A north Queensland doctor is warning he has “no faith” that regional Australia will see a mass distribution of the Pfizer vaccine.

The regional COVID-19 vaccine rollout has been thrown into turmoil by the Federal Government’s changed medical advice.

Last night, Prime Minister Scott Morrison told the country the AstraZeneca vaccine would no longer be recommended to people under 50 years old. 

The vaccine will still be available to those eligible, but recipients will be warned of the risk of blood-clotting. 

It comes as Queensland’s Chief Health Officer Jeannette Young announced every region across the state would be set up with a Pfizer vaccine hub, in light of the new TGA storage requirements.

Queensland Premier Annastacia Palaszczuk said the AstraZeneca vaccine would continue to be administered in the Torres Strait due to the high rates of COVID-19 in nearby Papua New Guinea. 

Michael Clements, a Townsville-based general practitioner and chair of Northern Australia Primary Health Limited, said he believed the announcement would likely delay the regional rollout even further.

“This setback is really going to generate more hesitancy and more of those conversations,” Dr Clements said.

“Sadly, that means the timeline to get Australia vaccinated and back on track and integrated into the international community is going to be stretched out for another six months, or even a year.

“We’re going to be locked down again, wearing masks again, and we’re going to have cancelled holidays, and we’re going to be missing out on seeing our loved ones.”

Dr Clements said the logistics of delivering more Pfizer vaccines would amplify the delay.

“It could be well into next year before Pfizer will have anywhere near the doses that we might need,” he said.

The Therapeutic Goods Administration (TGA) has changed its storage and transportation requirements on the vaccine.

While longer term storage at temperatures between -90C to -60°C is still required for unopened vials, the TGA has approved storage and transportation at domestic freezer temperatures (-25°C to -15°C) for up to two weeks.

Nine hundred kilometres west, Mount Isa general practitioner Michael Mbaogu has been administering the AstraZeneca vaccine to eligible residents of north-west Queensland.

Dr Mbaogu said rural and remote facilities would need more government support to administer the Pfizer vaccine.

“We would need support to acquire that particular type of vaccine freezer.”

However, Dr Mbaogu said it would still be possible without the technology, if there was a system where vaccines were frequently delivered to the clinic.

“I’m aware you can store the Pfizer vaccine in a regular vaccine fridge for up to 72 hours, so we can do that,” he said.

“If there is an arrangement to ship the vaccines to us, that would give us at least three days to use them; that is also workable.”

The Rural Doctors’ Association of Australia (RDAA) met with Deputy Chief Medical Officer Michael Kidd and Federal Health Department staff on Friday morning to discuss the regional rollout.

RDAA CEO Peta Rutherford said they had been assured access for rural areas would be a key point of discussion with states.

However, she said delivery of the vaccine would need to be re-thought in places like Queensland.

She said that in some states, vaccination hubs were not accessible to rural and remote areas.

“If they were able to create some hubs in places more inland —Toowoomba, Mount Isa — it can be distributed.

“Once [the Pfizer vaccine] is basically defrosted, for lack of a better word, it can be used within five days so with some good planning and some good co-ordination, we could actually do it.”

Ms Rutherford said it was essential teams of doctors and nurses, trained in delivering the Pfizer vaccine, were in place and able to travel to remote and rural communities 

With winter approaching, she said finding a solution was especially urgent.

“With our grey nomad season about to commence, and with school holidays, there’s a lot of movement across state borders,” Ms Rutherford said.

“We need to make sure that these frontline healthcare workers are given the same support and provision as frontline healthcare workers in the city.”

On the Darling Downs, Indigenous not-for-profit Carbal Medical Services is administrating a large proportion of Toowoomba’s vaccines.

CEO Brian Hewitt said increasing the supply of alternative vaccines was the Federal Government’s best option to maintain confidence in the rollout.

“We’re talking about a very, very rare possibility of a reaction to this vaccine – very rare compared to all other medicines and vaccines that are distributed,” Mr Hewitt said.

“Any concern in the current climate is likely to deter people from getting the vaccine, and that would be a far worse outcome than any side effects to any medication.”

Mr Hewitt said the Pfizer vaccine would not be a viable alternative for all communities.

“Outside of hospital situations, it’s very difficult to store and keep supplies of that for any length of time,” he said.

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